Oct 6 (Reuters) - The U.S. Food and Drug Administration saidnew data indicate that the generic version of the popularantidepressant Wellbutrin is not equivalent to the original drugmanufactured by GlaxoSmithKline.
Budeprion XL 300 mg, or bupropion hydrochlorideextended-release tablets, are manufactured by Impax LaboratoriesInc and marketed by Teva Pharmaceuticals USA Inc.
The FDA, in a notice posted on its website on Wednesday,said it has changed the therapeutic equivalence rating for theproduct in the agency's Approved Drug Products with TherapeuticEquivalence Evaluations to show that Budeprion XL 300 mg failsto demonstrate therapeutic equivalence to Wellbutrin XL 300 mg.
Impax has requested that the FDA withdraw approval ofbudeprion XL 300 mg extended-release tablets, the FDA said.Impax and Teva have stopped shipping the product, the agencysaid.
(Reporting by Debra Sherman; Editing by Will Dunham)
Keywords: FDA ANTIDEPRESSANT/